The U.S. Food and Drug Administration (FDA) has approved the use of a genetically-engineered growth hormone for injection into milk cows, the first genetically-engineered food product approved by FDA. As a result, the genetically-engineered hormone (called rBGH, or recombinant bovine growth hormone) will now appear in milk, cheese, yogurt, ice cream, dairy-derived hamburger, many processed foods such as baked goods, and baby formula. FDA says the genetically-engineered product is the same as ("not significantly different from") naturally-occurring bovine growth hormone (BGH) but some scientists have pointed out that this is not true. Natural BGH and the recently-approved rBGH differ in their chemical structures. [1] FDA says neither BGH nor rBGH has any biological effect in humans, but David S. Kronfeld of Virginia Polytechnic Institute and others ask whether rBGH may stimulate an immune response or an allergic reaction in some people. FDA says this possibility is "insignificant" and has refused to conduct human tests. [2] Whether people exhibit immune responses or allergic reactions to rBGH will now be discovered by exposing the general public to this drug. In essence, FDA has given rBGH producers permission to conduct a large-scale experiment on the public, without a control population.

Bovine growth hormone causes cows to produce more milk, but it does not act directly. Instead, BGH releases a chemical called IGF-1 ("insulin-like growth factor #1") which then causes increased milk production. [3] IGF-1 is a normal constituent of milk from both cows and humans. Several studies have shown that milk from rBGH-treated cows contains elevated concentrations of IGF-1. This is important because IGF-1 is chemically identical in cows and in humans--a fact FDA did not know when the agency first declared rBGH "safe" for human consumption in 1985. Thus rBGH-treated cows will very likely produce milk that contains increased levels of a growth factor known to be biologically active in humans. The consequences of this are unknown, but FDA has said the risks--whatever they may be--are worth taking. (FDA does not balance risks against benefits, but two benefits of rBGH use have been identified: an estimated $300 to $500 million in annual income to Monsanto, the only company presently marketing an FDA-approved rBGH, and an estimated 12% increase in the nation's supply of milk. Since the nation already produces more milk than it can use, the federal government will purchase the additional milk at an estimated cost to the taxpayer of $200 million or more per year.)

When an expert committee of the federal National Institutes of Health (NIH) examined the rBGH issue, it concluded that milk and meat from rBGH-treated cows are as safe as from cows not treated. However, they noted that, "Whether the additional amount of IGF-1 in milk from [rBGH-treated] cows has a local effect on the esophagus, stomach or intestines is unknown." Among the report's six recommendations was, "Determine the acute and chronic local actions of IGF-1, if any, in the upper gastrointestinal tract." [4] This has not been done. Perhaps the uncontrolled experiment now being conducted on the public by FDA and Monsanto will reveal new information on this point.

The NIH panel chose not to consider the issue of cow health or the secondary human health consequences of cow health. As we pointed out in RHWN #381 and #382, there is abundant evidence indicating that cows treated with rBGH are more prone to udder infections called mastitis. Mastitis infections add pus to milk. Because increased pus diminishes the value of milk, dairy farmers respond to mastitis with antibiotics, often unapproved and illegal antibiotics. (Mastitis presently costs dairy farmers $2 billion each year, or $200 per cow per year on the average dairy farm. [5])

Indeed, leaked internal documents reveal that Monsanto itself used several unapproved drugs to control mastitis increases in its rBGH test herds. [6]

In 1990, an FDA survey found antibiotics and sulfa drugs in 51% of 70 milk samples taken in 14 cities. [7] Subsequently FDA announced it had found no antibiotics in a follow-up survey, but the WALL STREET JOURNAL reported two months later that FDA had actually found drugs in 80% of the samples. [8] An FDA spokesperson acknowledged that antibiotics are "widely misused" by dairy farmers and veterinarians. [9]

A CBS-affiliated TV station in New York conducted its own survey of milk from stores in New York, New Jersey and Connecticut in early 1990 and reported that 80% of 50 samples contained tetracyclines, a family of antibiotics. The survey also revealed that 26% of the samples were tainted with the drug sulfamethazine, a suspected carcinogen banned from dairy use. [10]

In 1993, federal General Accounting Office (GAO) recommended that FDA not approve rBGH until the question of secondary health effects (mastitis --> antibiotics --> humans) has been resolved. On March 2, 1993, the GAO sent a letter to Donna Shalala, Secretary of Health and Human Services (of which FDA is a part) saying that in interviews FDA officials "did... acknowledge the possibility that there was an antibiotic-human food safety concern that they should investigate." But, GAO said, subsequent communications from FDA "did not address our concern: does rBGH use result in higher concentrations of antibiotics in milk or not, and if so, is the higher level acceptable from a food safety standpoint?" The GAO went on to note that FDA has said its review of human food safety issues has been completed. GAO asked, "But how can a food safety determination be made when the rBGH-mastitis-antibiotic issue has not been addressed, much less resolved?" "In conclusion," the GAO said, "we would like to point out that the increase in mastitis levels reported in the rBGH pivotal studies suggests that the potential for an increase in milk antibiotic levels is very real... [The FDA's] response suggests that our recommendations have not been seriously addressed." [11] FDA went ahead and approved rBGH.

How can Monsanto risk an experiment on the milk supply of the American public? If widespread harm should occur, might not the company be liable for billions of dollars in damages and possible bankruptcy?

Luckily for Monsanto, and others similarly situated, recent court rulings have provided safe shelter for corporations whose consumer products result in massive litigation.

The new corporate shelter was invented by Judge Jack Weinstein in the case of Vietnam veterans seeking damages from Dow, Diamond Shamrock, Monsanto and other companies that produced Agent Orange. Agent Orange was an herbicide used in Vietnam to defoliate jungles. Many American troops exposed to the chemical during the war say they and their children were harmed. The National Academy of Sciences and the Veterans Administration in 1993 said the vets WERE harmed. [12]

The courts allowed the companies to settle with some of the plaintiffs for a fixed amount, with the stipulation that no future lawsuits can be brought against the Agent Orange manufacturers, even by people who weren't party to today's settlement because they did not know they had been harmed. In future, if a person develops a disease they believe was caused by Agent Orange, they cannot sue --their Constitutional right to due process was extinguished by the original settlement.

This is exceptionally important because litigation typically proceeds in stages. As we saw in the case of asbestos, each new lawsuit brings forth more evidence of what a company knew when. Jury awards and penalties increase as a company's deceptions and coverups are progressively revealed. The first plaintiffs may fail completely, but the 20th or 50th may be awarded many millions of dollars in compensatory and punitive damages, as the courts see, and then punish companies for, a pattern of unethical behavior.

The new legal doctrine cuts off the possibility of a series of suits against a company, thus providing almost complete protection against suits that might cause bankruptcy.

This new legal doctrine has recently been used to limit the liabilities of companies that marketed silicone breast implants. It is a creative legal invention which sharply limits the liability of corporations that market possibly-harmful products that have not been fully tested for safety. Recently more than 8 million Vietnam veterans asked the U.S. Supreme Court to review this new legal doctrine, on the ground that their Constitutional rights had been taken from them. The attorney generals of all 50 states joined with the vets asking the Supreme Court to review this new doctrine. [13] The Supreme Court refused. And that is one reason why companies are willing to risk exposing the general public to drugs in their food without fully understanding the consequences. Under doctrines invented by the Reagan/Bush courts, corporations are protected but the public is not.
                                                                         --Peter Montague, Ph.D.
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[1] A reader, Robert Plano, points out that in RHWN #382 we erroneously understated the degree of difference between natural BGH and Monsanto's synthetic rBGH; in RHWN #382 we said rBGH is natural BGH with an amino acid (methionine) added; in fact, Plano points out, FDA says Monsanto's product is the natural BGH with one amino acid removed (alanine) and another added (methionine); see Judith C. Juskevich and C. Greg Guyer, "Bovine Growth Hormone: Human Food Safety Evaluation." SCIENCE Vol. 249 (1990), pg. 877. FDA says these differences make no difference.

[2] David S. Kronfeld, "Recombinant Bovine Growth Hormone: Cow Responses Delay Drug Approval and Impact Public Health" in William C. Liebhardt, THE DAIRY DEBATE; CONSEQUENCES OF BOVINE GROWTH HORMONE AND ROTATIONAL GRAZING TECHNOLOGIES (Davis, Cal.: University of California Sustainable Agriculture Research and Education Program, 1993), pgs. 67-112. Kronfeld raised this point in "Safety of Bovine Growth Hormone," SCIENCE Vol. 251 (January 18, 1991), pg. 256, and FDA responded in SCIENCE Vol. 251 (January 18, 1991), pgs. 256-257.

[3] T. B. Mepham, "Public health implications of bovine somatotrophin [sic] use in dairying: discussion paper," JOURNAL OF THE ROYAL SOCIETY OF MEDICINE Vol. 85 (December 1992), pgs. 736-739.

[4] Melvin M. Grumbach and others, "NIH Technology Assessment Conference Statement on Bovine Somatotropin," JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION Vol. 265 No. 11 (March 20, 1991), pgs. 1423-1425.

[5] William M. Murphy and John R. Kunkel, "Sustainable Agriculture: Controlled Grazing vs. Confinement Feeding of Dairy Cows," in William C. Liebhardt, THE DAIRY DEBATE; CONSEQUENCES OF BOVINE GROWTH HORMONE AND ROTATIONAL GRAZING TECHNOLOGIES (Davis, Cal.: University of California Sustainable Agriculture Research and Education Program, 1993), pg. 121.

[6] Samuel S. Epstein and Peter Hardin, "Confidential Monsanto Research Files Dispute Many BGH Safety Claims," THE MILKWEED [Madison, WI; phone: 608/455-2400] Vol. 128 (1990), pgs. 3-6, discussing P.J. Eppard and others, TOXICITY OF CP115099 IN A PROLONGED RELEASE SYSTEM IN LACTATING COWS. REPORT MSL 6345. (St. Louis, Mo.: Monsanto Agricultural Co., 1987).

[7] Bruce Ingersoll, "Technology & Health: FDA Detects Drugs in Milk But Fails to Confirm Results," WALL STREET JOURNAL February 6, 1990, pg. B6.

[8] Bruce Ingersoll, "Politics and Policy: GAO Says FDA Can't Substantiate Claims About Milk," WALL STREET JOURNAL November 21, 1990, pg. A16.

[9] Bruce Ingersoll, "Technology & Health: FDA Plans a Nationwide Test of Milk for Antibiotics, Other Drug Residues," WALL STREET JOURNAL December 28, 1990, pg. 10.

[10] Bruce Ingersoll, "New York Milk Supply Highly Tainted, TV Station Says, Based on Own Survey," WALL STREET JOURNAL February 8, 1990, pg. unknown.

[11] Correspondence from Eleanor Chelimsky, Assistant Comptroller General, General Accounting Office, to Donna E. Shalala, Secretary of Health and Human Services, March 2, 1993.

[12] Institute of Medicine, VETERANS AND AGENT ORANGE: HEALTH EFFECTS OF HERBICIDES USED IN VIETNAM (Washington, D.C.: National Academy Press, 1993).

[13] P.B. Onderonk, Jr. and others, "No. 93-860 In the Supreme Court of the United States, October Term, 1993, Shirley Ivy... v. Diamond Shamrock... on Petition for Writ of Certiorari to the United States Court of Appeals for the Second Circuit."

Descriptor terms: fda; genetic engineering; biotechnology; rbgh; bgh; bst; rbst; recombinant bovine growth hormone; food safety; david s kronfeld; immune system; allergies; allergens; milk; hormones; igf-1; insulin-like growth factor 1; nih; national institutes of health; monsanto; cows; animal health; mastitis; antibiotics; sulfa drugs; tetracyclines; sulfamethazine; carcinogens; general accounting office; donna shalala; health and human services department; hss; hssd; gao;